Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US LUPINE STABILIZATION FISHMOUTH DRGDE *EA; SURGICAL HAND DRILL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY MITEK LLC US LUPINE STABILIZATION FISHMOUTH DRGDE *EA; SURGICAL HAND DRILL Back to Search Results
Model Number 213817
Device Problems Break (1069); Dull, Blunt (2407)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/10/2020
Event Type  malfunction  
Manufacturer Narrative
Udi: (b)(4) incomplete.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event Description
It was reported by the sales rep that during a shoulder repair procedure, it was observed that two of the fishmouth drill guide and two of the drill bit (stabilization) were dull and created metal shavings.All fragments were retrieved from the patient´s body.The procedure was completed using the same device.No patient consequences or surgical delay reported.No additional information was provided.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: additional information: d4, h4: the lot number has been updated as 18f01 to reflect the correct information.Therefore, the device manufacture date and have been updated accordingly.Udi: (b)(4).
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: d10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H6: method codes: a manufacturing record evaluation was performed for the finished device [18f01] number, and no non-conformances were identified.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary : according to the information provided, it was reported that during a shoulder repair procedure two of the fishmouth drill guide and two of the drill bit (stabilization) were dull and created metal shavings.The complaint device was received and inspected.Visually, the device appears worn and laser markings are slightly faded.Under magnification, the handle has nicks and marks.This failure could be attributed to normal field wear due to its condition.However, it cannot be conclusively affirmed.For further investigation, it was reviewed with the external manufacturer to determine additional information about if there were any internal issues which would have contributed to the nature of the product complaint.The device history record was made; as a result, the manufacture date was during june-august 2018.In the last 3 years, there are not similar complaints.In addition, this failure seems to be one off incident.A closer investigation about the fishmouth drill guide was performed; the engineering department concluded that it is important to follow the ifu-107066 instruction before used the device in the procedure.The main points are that it is necessary to inspect the damage prior use and the device is a delicate instrument because of this, required a cleaning processing specific to avoid damaging it.Therefore, the issue is not manufacturing related and we cannot confirmed this complaint.Since there are no more information of the defect reported we cannot discern a root cause, but it could be related to did not follow up the ifu instruction.A manufacturing record evaluation was performed for the finished device [18f01] number, and no non-conformances were identified. at this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of Device
SURGICAL HAND DRILL
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key10201768
MDR Text Key196752604
Report Number1221934-2020-01663
Device Sequence Number1
Product Code FZX
UDI-Device Identifier10886705003280
UDI-Public10886705003280
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup
Report Date 06/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number213817
Device Catalogue Number213817
Device Lot Number18F01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2020
Date Manufacturer Received08/06/2020
Patient Sequence Number1
-
-